DiphtheriaPhase 3ClodivacNCT05480462
Immunogenicity and Safety of Vaccine Against Tetanus and Diphtheria.
A Phase 3 study testing Clodivac and Td-Impfstoff Merieux in people with Diphtheria and Tetanus, run by IBSS Biomed S.A. at 2 sites in Poland.
Trial summary
A single blind, randomized, comparative, multicentre clinical trial of the immunogenicity and safety of booster immunization with bivalent vaccine against tetanus and diphtheria CLODIVAC (IBSS BIOMED S.A.) and Td-Impfstoff Mérieux (Sanofi Pasteur) in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diphtheria, Tetanus
- What is being tested?
- Clodivac and Td-Impfstoff Merieux
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesPoland
- Study dates
- 12 Dec 2022to Jun 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Approved informed consent.
- Men and women aged 18- 65 years.
- Written confirmation on previous immunization against diphtheria and tetanus not older than 16 years and not younger than 4 years.
Who cannot join
- Subject with acute infectious diseases.
- Subject allergic to any of the substances of the IMP administered in clinical trial.
- Subject with Guillain-Barré syndrome or neuropathy, an anaphylactic or other allergic reactions after previous vaccination against tetanus or diphtheria.
- Subject with primary or secondary immunodeficiency (e.g. congenital immunodeficiency, HIV infection, organ or bone marrow transplantation, leukemia, lymphoma, Hodgkin's disease, multiple myeloma, generalized malignancy, drugs or other causes induced immunodeficiency).
- Subject with progressive or unstable neurological disorder.
- Subject with severe thrombocytopenia or any coagulation disorder not allowing the intramuscular administration.
Show all 14Show fewer
- Subject with blood product treatment, including immunoglobulins within the last 90 days prior to study entry.
- Subject vaccinated less than 14 days inactivated or live vaccine prior to study entry.
- Pregnant woman and breastfeeding (anamnestically).
- Subject incapable of cooperation.
- Alcohol or drug abuse.
- Subject currently participating in another clinical trial or in drug evaluation, within 4 weeks prior to study entry.
- Subjects requiring vaccination against tetanus after severe injury.
- Any other condition that in the Investigator's opinion may affect the safety of the test participant or the integrity of data obtained during the study.
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
SPZOZ w Bochni Szpital Powiatowy im. bł. M. Wieckiej
Bochnia
Krakowski Szpital Specjalistyczny im. Jana Pawła II
Krakow
About this study
Official title: Single Blind, Randomized, Comparative, Multicentre Clinical Trial of the Immunogenicity and Safety of Booster Immunization With Bivalent Vaccine Against Tetanus and Diphtheria CLODIVAC (IBSS Biomed S.A.) and Td-Impfstoff Mérieux (Sanofi Pasteur) in Healthy Adults.
A single blind, randomized, comparative, multicentre clinical trial of the immunogenicity and safety of booster immunization with bivalent vaccine against tetanus and diphtheria CLODIVAC (IBSS BIOMED S.A.) and Td-Impfstoff Mérieux (Sanofi Pasteur) in healthy adults.
- Conditions
- Diphtheria, Tetanus
- Being tested
- Clodivac, Td-Impfstoff Merieux
- Keywords
- Vaccine, Booster
- Medical subject headings
- Diphtheria, Tetanus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClodivacBiological
A dose of 0.5 ml should be administered intramuscularly into deltoid muscle.
Td-Impfstoff MerieuxBiological
One dose (0.5 ml) intramuscular, preferably in the deltoid muscle of the upper arm.
| Study group | Role | What they receive |
|---|---|---|
| Clodivac | Experimental | Not described Receives: Biological: Clodivac |
| Td-Impfstoff Merieux | Active comparator | Not described Receives: Biological: Td-Impfstoff Merieux |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion
The primary endpoint is the seroconversion in 28 days follow-up. The proportion of subjects complying the positive criteria of seroconversion will be calculated.
Measured: 28 days
Secondary outcomes (1)
The ratio of geometric mean concentrations (GMC) of post-vaccination tetanus antibodies and diphtheria antibodies between test and reverence.
- The ratio of geometric mean concentrations (GMC) of post-vaccination tetanus antibodies between test and reference vaccine in 28 days FU.
- The ratio of geometric mean concentrations (GMC) of post-vaccination diphtheria antibodies between test and reference va1. The ratio of geometric mean concentrations (GMC) of post-vaccination tetanus antibodies between test and reference vaccine in 28 days FU.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start12 Dec 2022
- Primary completion4 Mar 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiphtheriaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IBSS Biomed S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05480462
- Sponsor's protocol ID
- 21-BIO-0002
- Acronym
- Clodivac
- Status last verified
- Feb 2024
- First submitted
- 27 Jul 2022
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Blind, Randomized, Comparative, Multicentre Clinical Trial of the Immunogenicity and Safety of Booster Immunization With Bivalent Vaccine Against Tetanus and Diphtheria CLODIVAC (IBSS Biomed S.A.) and Td-Impfstoff Mérieux (Sanofi Pasteur) in Healthy Adults.
- ClinicalTrials.gov ID
- NCT05480462
- Acronym / sponsor ID
- Clodivac / 21-BIO-0002
- Conditions
- Diphtheria, Tetanus
- Keywords
- Vaccine, Booster
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- IBSS Biomed S.A.Industry (pharma, biotech, devices)
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 4 Mar 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 29 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A single blind, randomized, comparative, multicentre clinical trial of the immunogenicity and safety of booster immunization with bivalent vaccine against tetanus and diphtheria CLODIVAC (IBSS BIOMED S.A.) and Td-Impfstoff Mérieux (Sanofi Pasteur) in healthy adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clodivac | Experimental | Biological: Clodivac |
| Td-Impfstoff Merieux | Active comparator | Biological: Td-Impfstoff Merieux |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Approved informed consent.
- Men and women aged 18- 65 years.
- Written confirmation on previous immunization against diphtheria and tetanus not older than 16 years and not younger than 4 years.
Key exclusion criteria (14 listed)
- Subject with acute infectious diseases.
- Subject allergic to any of the substances of the IMP administered in clinical trial.
- Subject with Guillain-Barré syndrome or neuropathy, an anaphylactic or other allergic reactions after previous vaccination against tetanus or diphtheria.
- Subject with primary or secondary immunodeficiency (e.g. congenital immunodeficiency, HIV infection, organ or bone marrow transplantation, leukemia, lymphoma, Hodgkin's disease, multiple myeloma, generalized malignancy, drugs or other causes induced immunodeficiency).
- Subject with progressive or unstable neurological disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClodivacA dose of 0.5 ml should be administered intramuscularly into deltoid muscle. | Biological | Clodivac |
| Td-Impfstoff MerieuxOne dose (0.5 ml) intramuscular, preferably in the deltoid muscle of the upper arm. | Biological | Td-Impfstoff Merieux |
Primary outcome
Seroconversion
Time frame: 28 days
The primary endpoint is the seroconversion in 28 days follow-up. The proportion of subjects complying the positive criteria of seroconversion will be calculated.
1 secondary outcome
The ratio of geometric mean concentrations (GMC) of post-vaccination tetanus antibodies and diphtheria antibodies between test and reverence.
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Diphtheria
RecruitingPhase 2
A Phase II Clinical Trial of Absorbed Acellular Pertussis (Two-Component) Diphtheria-Tetanus Combined Vaccine (For Adults and Adolescents)
Pertussis (Whooping Cough), Diphtheria
RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
RecruitingPhase 4
Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy
RSV, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination
Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization
Active, not recruitingPhase 3
A Study on the Immune Response and Safety of a Combined Vaccine Against Diphtheria, Tetanus and Acellular Pertussis (dTpa) in Japanese Healthy Pregnant Women
Diphtheria-Tetanus-acellular Pertussis Vaccines
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Clodivac and Td-Impfstoff Merieux in people with Diphtheria and Tetanus, run by IBSS Biomed S.A. at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroconversion (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024.